Kornimate/medical-research-clean huggingface dataset:
once daily metronidazole for perforated appendicitis

Conditions: Appendicitis

Summary: the objective of this study is to determine whether administering once-daily doses of metronidazole, an intravenous (iv) antibiotic used to prevent infection in perforated appendicitis, is as effective in children as delivering it in the standard method of once every eight hours. reducing the frequency of administration has the potential of decreasing personnel time and healthcare cost and increasing the lifespan of the iv line. to determine the effectiveness once-daily administration, a randomized controlled trial (rct) will be conducted to compare outcomes between the two treatment schedules. we will recruit 100 patients (50 per treatment) aged 5-18 being surgically treated for perforated appendicitis at the children's hospital of eastern ontario, who will be randomly assigned to one of the two treatment schedules. to compare the efficacy of the treatments, outcomes such as duration of hospital stay and theoretical cost will be measured and analyzed using statistical tests.


Eligibility criteria:
inclusion criteria: * all children 5-18 years of age, presenting to cheo with perforated appendicitis (confirmed either in the operating room or diagnosed preoperatively according to radiological criteria), and managed surgically will be assessed for eligibility to participate. these patients may participate if baseline lab values of serum ast (sgot), al t (sgpt), ldh, triglycerides and hexokinase glucose are normal, complete physical exam is normal, hgc test is negative for pregnancy (if the patient is a female of reproductive age) and none of the exclusion criteria are present. exclusion criteria: * any known co-existing gastrointestinal disease * uncertainty about the diagnosis * perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis * a known allergy to any of the antibiotics to be used in this trial * an active neurological disorder * receiving medical treatment for a neurological disorder * a history of blood dyscrasia, hypothyroidism or hypoadrenalism * hepatic disease * renal impairment * patients receiving any other oral or intravenous concomitant antimicrobial at enrollment * pregnancy * under five years of age * patients who have received metronidazole orally or intravenously in the last 14 days, prior to the current admission for appendicitis * patients already taking any of the following medications at admission (as these may interact with metronidazole as stated in the product monograph): disulfiram, oral anticoagulant therapy (warfarin type), phenytoin or phenobarbital, vecuronium, lithium, busulfan * the physician elects to treat the patient conservatively (non-surgically)
moxibustion for the prevention of hemorrhagic cystitis after allo-hsct

Conditions: Moxibustion; Hematopoietic Stem Cell Transplantation; Hemorrhagic Cystitis; Prevention

Summary: this study was a prospective, multicenter, randomized controlled clinical study planned to recruit 266 hematological patients with allogeneic hematopoietic stem cell transplantation (allo-hsct), who were randomly divided into two groups according to gender, type of transplantation, and type of primary disease. the control group was treated conventionally, and the experimental group increased moxibustion of zhongji, guanyuan and qihai for 30 min qd starting on the first day after hsct was performed until the 14th day after transplantation. urine routine tests were performed at the time of admission, +1d, and +14d, and urine bk virus, jc virus, and adenovirus were tested at four time points, namely, +1d, +14 days, onset of hematuria symptoms, and remission of hc, respectively; routine urine tests were performed once every 7 days for all patients within 100days. for patients with hemorrhagic cystitis (hc), daily severity grading, pain scoring, cystitis symptom scoring, use of antispasmodic and analgesic medications, and major tcm evidence were recorded with the aim of evaluating the efficacy of moxibustion in the prevention of hc in this patient population.


Eligibility criteria:
inclusion criteria: 1. patients are fully aware of the study, participate voluntarily and sign the informed consent form (icf); 2. age: 14-60 years; 3. patients with pernicious blood diseases undergoing allo-hsct using the mac protocol or patients with severe aplastic anemia (severe aplastic anemia; severeaplasticanimin, saa) undergoing allo-hsct; exclusion criteria: 1. refuse to participate in this clinical study; 2. the corresponding skin at the moxibustion site is broken or sensitive; 3. allo-hsct pretreated with the ric program;
long-term efficacy, tolerance and compliance of panthera d-sad® mandibular advancement orthosis in sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: obstructive sleep apnea (osa) is a common, chronic and serious medical condition. oral appliance therapy (oat) also called mandibular advancement orthosis (mao) provides long-term therapy for osa patients. the panthera d-sad® is a computer aided design (cad)/computer aided manufacturing (cam), patient-matched, 3d printed, biocompatible nylon oat. this five-year, observational prospective and multicenter study will assess the effectiveness of the panthera d-sad® orthosis on reducing the apnea hypopnea index (ahi) and obstructive sleep apnea-hypopnea syndrome (osahs) symptoms. adherence, tolerance, and side effects will be evaluated. an estimated ten sites composed of a professional dyad, a specialist in sleep disorders, and a practitioner with knowledge of both sleep and the manducatory apparatus will recruit 337 patients. the entry criteria include an ahi between 15 and 30 or higher if the patient meets certain medical and dental criteria, no prior use of oat, and struggles or refuses continuous positive airway (cpap) treatment. the professional collaborative nature of the study reflects real-world clinical practice. participants will be followed over the course of five years at the following time points. visits include the following: specialist in sleep disorders: (1) inclusion, (2) 3 months, (3) 2 years, (4) 5 years. specialist in manducatory apparatus (dentist): (1) inclusion, orthosis set-up and titration, (2) 6 months, (3) 2 and (4) 5 years the efficacy of the panthera d-sad® mao will be assessed by the treatment success rate at five years, defined as a reduction ≥ 50% in the initial ahi, when monitored by nocturnal breathing polygraphy (np) or polysomnography (psg). secondary endpoints will also be obtained at the aforementioned time points for reporting. the results of this study will fulfill regulatory requirements for reimbursement in france.


Eligibility criteria:
inclusion criteria: * male or female ≥18 * moderate osahs or severe osahs and refuse or intolerance to treatment with continuous positive pressure * patient who has never worn mao * accepting and able to complete questionnaires in french on the impact of their disease and their quality of life * informed and having signed a written consent * affiliated to a social security system exclusion criteria: * one or more contraindications to wearing a mandibular advancement orthosis * central sleep apnea * severe osahs associated with another sleep pathology * serious respiratory disorders other than osas * severe psychiatric or neurological disorders * progressive cancer and/or chronic joint, inflammatory or immunosuppressive disease * known allergy to one of the components of the medical device * simultaneous participation in another intervention research * vulnerable subjects

Keywords: obstructive sleep apnea hypopnea syndrome (osas) snoring mandibular advancement orthosis panthera d-sad
evaluation of peginterferon alfa-2b monotherapy and combination with ribavirin in participants with acute hepatitis c (p03552/mk-4031-137)

Conditions: Hepatitis C

Summary: the objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (peg-ifn) either as monotherapy or in combination with ribavirin in participants with acute hepatitis c. after 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of peg-ifn monotherapy (peg-ifn 24); or (2) a 12-week course of peg-ifn monotherapy (peg-ifn-12); or (3) a 12-week course of peg-ifn in combination with ribavirin (peg-ifn + rvb 12). after the treatment period, participants will enter a 12-month follow-up.


Eligibility criteria:
inclusion criteria: * diagnosed with acute hepatitis c virus (hcv). * normal and elevated serum alanine transferase (alt) levels * positive serum hcv-rna. * aged between 18 and 65 years. * negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion exclusion criteria: * liver disease unrelated to hcv infection * hemoglobin (hgb) \<12g/dl in women and \<13g/dl in men; white blood cells (wbc) \<3,000/ul; platelets (plts) \<100,000/ul * women with ongoing pregnancy or who are breast feeding * history of severe psychiatric disease, especially depression * history of neurologic disease, especially epilepsy * history or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease * positive anti-human immunodeficiency virus (hiv) antibodies * positive anti-nuclear antibodies (ana) and/or anti-smooth muscle antibody (asma) (\>1/80) * positive hepatitis b surface antigen (hbsag) * history of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months * history or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)
study of bavituximab plus paclitaxel and carboplatin in patients with non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the primary objective of this study is to determine the overall response rate (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small cell lung cancer.


Eligibility criteria:
key inclusion criteria: * adults over age 18 years of age with a life expectancy of at least 3 months * histologically or cytologically confirmed non-small cell lung cancer at stage iiib (with pleural effusion), stage iv, or recurrence * measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral ct) * adequate hematologic (anc ≥ 1500 cells/µl; hemoglobin ≥9 g/dl; platelets ≥100,000/µl and ≤500,000/µl ), renal (serum creatinine ≤ 1.5 mg/dl or calculated creatinine clearance ≥ 60 ml/min), and hepatic function (bilirubin ≤ 1.5 x uln, alt ≤ 3 x uln, ast ≤ 3 x uln) * d-dimer ≤ 2 x uln key exclusion criteria: * small cell or mixed histology * known history of bleeding diathesis or coagulopathy * any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gi bleeding * any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) * prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy * radiotherapy within 2 weeks preceding study day 1 * symptomatic or clinically active cns disease or metastatic lesions * major surgery within 4 weeks of study day 1 * uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease) * any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack * a history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. anti-platelet agents are prohibited during the study. * requirement for chronic daily treatment with nsaids, anti-platelet drugs, or steroids

Keywords: nsclc
dc-cik combined with tace in the treatment of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Neoplasms; Digestive System Neoplasms

Summary: evaluation of dc-cik cells combined tace treatment for hcc

60 patients with hepatocellular carcinoma, who had received transcatheter arterial chemoembolization (tace) , will be randomly divided into group a (receive dc-cik+ tace treatment) or group b (just receive tace), and the randomize ratio will be 1:1.

Eligibility criteria:
inclusion criteria: * 18-80 years old; * histologically confirmed with hepatocellular carcinoma at stage i-ii; * patients who can accept transcatheter arterial chemoembolization ; * patients who have a life expectancy of at least 3 months; * patients who have a child-pugh:a/b; .eastern cooperative oncology group (ecog) performance status was 0-2. exclusion criteria: * white blood cell \<3 x 10\^9/l,platelet count \<75 x 10\^9/l;bun and cr more than normal limits on 3.0 times ; * known or suspected allergy to the investigational agent or any agent given in association with this trial; * pregnant or lactating patients; * known history of human immunodeficiency virus (hiv), hepatitis c virus (hcv) or treponemapallidun (tp) infection; * patients who are suffering from serious autoimmune disease; * patients who had used long time or are using immunosuppressant; * patients who had active infection; * prior use of any anti-cancer treatment in 30 days; * now or recently will join another experimental clinical study ; * history of organ allograft; * other situations that the researchers considered unsuitable for this study
health related quality of life of youth and young adults with haemophilia a

Conditions: Hemophilia A

Summary: research question: whether there are the changes in quality of life in patients with haemophilia a after switching from shl fviii prophylaxis to efmoroctocog alfa prophylaxis? a 12-month prospective open-label, single-arm multicentre study. evaluation of parameters will be carried out on the backdrop of patient treatment in the settings of routine medical practice. no medical examinations/ procedures/ treatment(s) on the top of regular medical practice are planned, except fixed time of examinations.

quality of life is among the key factors when medical decision about management of haemophilia is taken. there are no scientific data on the hrqol in patients after switching from standard half life (shl) fviii prophylaxis to efmoroctocog alfa (extended half life, ehl) prophylaxis in russia. it will be a 12-month prospective open-label, single-arm multicentre study. evaluation of parameters will be carried out on the backdrop of patient treatment in the settings of routine medical practice. no medical examinations/ procedures/ treatment(s) on the top of regular medical practice are planned, except fixed time of examinations. providing the centers/ patients with the study drug (efmoroctocog alfa) may be considered as interventional component, whereas all administrations should be in accordance with instruction on medical use approved by russian ministry of health. research question: whether there are the changes in quality of life in patients with haemophilia a after switching from shl fviii prophylaxis to efmoroctocog alfa prophylaxis? no hypothesis is formulated for this exploratory study. the obtained data will be used to assess real world data on quality of life and clinical outcomes in patients with haemophilia a after switching from shl fviii prophylaxis to efmoroctocog alfa prophylaxis in routine medical practice in russia

Eligibility criteria:
inclusion criteria: 1. signed consent form. 2. adults, adolescents and children (12-25 years old) with haemophilia a with abr ≥ 2 on at least one-year shl fviii prophylaxis. exclusion criteria: 1. patients who have had hypersensitivity reactions to efmoroctocog alfa or other constituents of the product. 2. history of factor viii inhibitors. 3. patients who have other haemostatic disorders. 4. patients participating in interventional studies.

Keywords: haemophilia a health-related quality of life efmoroctocog alfa
the effectiveness of over the counter hearing products for middle-aged adults

Conditions: Hearing Loss, Functional

Summary: the investigators will examine the effectiveness of selected over-the-counter personal sound amplifiers in addressing functional hearing problems in middle-aged listeners with mild hearing loss. many people are unlikely to pay several thousand dollars for hearing aids but they likely would be more willing to try a possible solution that is less expensive. when faced with counseling these individuals, audiologists are at a loss regarding whether or not to suggest that they try this type of technology, since there is virtually no research available to verify that these devices actually are helpful, particularly for individuals with mild hearing loss. the hypothesis being tested is that personal sound amplifiers can improve functional hearing and decrease cognitive load in complex auditory environments.

the field trials in this project will require you to use otc hearing devices for a specified period of time in both ears simultaneously, and in just one ear, with periodic lab-based re-evaluation. each field trial will continue until asymptotic performance is identified (up to a maximum of 12 weeks). you will return to the lab for assessment every 2 weeks. during each visit, speech perception and subjective listening effort will be assessed. depending upon the specific field trial, the investigators also will complete measures of cognitive load (via dual-task paradigms), spatial release from masking, and localization ability during each lab visit.

Eligibility criteria:
inclusion criteria: * age 40-64 years * mild to moderate high frequency hearing loss * learned english as a first language exclusion criteria: * previous use of hearing aids * hearing loss/problems attributed to factors other than aging * history of: neurologic disorder, middle-ear disease * score of \< 26 on the montreal cognitive assessment
a study to assess the change in disease state in adult participants being treated with oral upadacitinib tablets in participants with oligo- or poly-articular psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: psoriatic arthritis (psa) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. it is caused by the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. the main objective of this study is to characterize attainment of minimal disease activity (mda) at week 24 under continuous treatment with upadacitinib in participants with oligo- or polyarticular psa as part of real-world practice. upadacitinib is a drug approved for the treatment of psoriatic arthritis (psa) in germany and canada. approximately 380 adult participants with psa at multiple sites in germany and canada. participants will receive oral upadacitinib tablets per current local label, according to local standard of care and international guidelines. there may be a higher burden for participants in this study compared to standard of care. participants will attend regular visits per routine clinical practice. the effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.


Eligibility criteria:
inclusion criteria: * diagnosis of active psoriatic arthritis (psa) upon judgment of the treating physician. * swollen joint count (sjc) \>= 1 out of 66 joints. * decision on the treatment with upadacitinib was made prior to any decision to approach the participant to participate in this study. exclusion criteria: * cannot be treated with upadacitinib according to the local upadacitinib summary of product characteristics (smpc). * prior treatment with upadacitinib. * currently participating in interventional research or within the last 30 days.

Keywords: psoriatic arthritis oligoarticular psoriatic arthritis polyarticular psoriatic arthritis upadacitinib rinvoq
the effect of a new type of pelvic floor rehabilitation device phenix u4+ on the treatment of urinary incontinence

Conditions: Urinary Incontinence

Summary: enrolled patients with urinary incontinence in peking university people's hospital, wuhan people's hospital, zhongshan people's hospital, and jiangsu maternity and child health hospital in the department of gynecology, and collected baseline data. the random number table was used to divide the period into observation group and control group. the observation group was treated with a new type of pelvic floor rehabilitation therapy device phenix u4+, and the control group was treated with a traditional pelvic floor electrical stimulation therapy device. follow-up observations during the treatment period and at the end of the treatment, 3 months and 6 months, the main follow-up content includes 1h pad test, 72-hour urination diary, modified oxford muscle strength classification diagnosis, urinary incontinence-related questionnaires, new equipment inspections, etc. , track and compare the treatment effect.

use two pelvic floor treatment devices to treat urinary incontinence, collect relevant questionnaires and pelvic floor muscle strength, and compare the two treatment devices.

Eligibility criteria:
inclusion criteria:1) 18 years old and above; 2) have a history of sexual life; 3) plan to live locally for a long time; 4) mild to moderate pressure, urgency or mixed urinary incontinence; 5) the patient agrees to conduct the study and signs an informed consent form. exclusion criteria: 1. combined pelvic organ prolapse (with extrahymen bulging); 2. obesity (bmi\>28kg/m2, bmi=weight (kg)/height square (m2)); 3. uncontrolled asthma and chronic obstructive pulmonary disease (copd); 4. combined connective tissue disease; 5. women with unclean lochia during pregnancy, within 6 weeks of postpartum and postpartum 6. malignant tumors; 7. combined neurological diseases (patients with epilepsy and dementia); 8. those with a synchronized pacemaker on their chest (biofeedback can be done).

Keywords: new type of pelvic floor rehabilitation device phenix u4+ traditional pelvic floor electrical stimulation therapy instrument
the effect of anesthesia type on rirs

Conditions: Renal Stone

Summary: retrograde intrarenal surgery (rirs) with flexible ureteroscopy is based on video monitoring of urinary tract during operation. therefore, shaking vision on monitor can bother surgeons and make them tired. this can lead in tissue injury from lasing. the purpose of this study is to investigate the stability of monitoring of surgical field which is assessed by surgeon.

rirs with flexible ureteroscopy is usually performed under general anesthesia, spinal anesthesia. anesthesia type is decided in the basis of medical condition of a patient and patient's preference. this study is a prospective observational study. during operation after induction of anesthesia, surgeons will be asked how visual stability of surgical field on monitor is (scale from 0 to 10). according to anesthesia type (general anesthesia, spinal anesthesia), 34 patients will be enrolled and investigated in each group. investigators will compare the scale for visual stability of surgical field during rirs.

Eligibility criteria:
inclusion criteria: * patients requiring rirs because of renal stone. exclusion criteria: * disagreement for the trial.